Title: Department: Personnel: Intravenous Admixture Program Pharmacy All Pharmacy Personnel Effective Date: 3/4/95 Revised: 04/08, 7/11, 7/14 Page 1 of 17 Purpose: It is SpringhillMedicalCenter s intent to provide patients with compounded sterile products using medically appropriate drugs and solutions prepared in accordance with USP and AlabamaState Board of Pharmacy standards. SMC uses practice guidelines set forth in USP Chapter 797 to ensure sterility, purity, compounding accuracy, labeling accuracy, proper storage and handling of compounded sterile products. FACILITY REQUIREMENTS and RESTRICTIONS Springhill Medical Center Pharmacy shall be registered with The Alabama State Board of Pharmacy as a parenteral pharmacy. Compounding of sterile preparations, other than those prepared for immediate use in patient care areas, shall be prepared in the Pharmacy s segregated compounding area, within one of three Primary Engineering Controls (PECs).These PECs are: 1) Class II, Type A/B3 Laminar Flow Biological Safety Cabinet. 2) Class II, Type A Externally Exhausted Laminar Flow Biological Safety Cabinet. 3) ISO Class 5 Containment Aseptic Isolator. Only low risk and medium risk Compounded Sterile Preparations (CSP s)are prepared at Springhill Medical Center. High risk CSPs are not prepared at SMC. Risk levels are as defined in USP Chapter 797. Medications considered hazardous or cytotoxic are prepared following USP Chapter 797 guidelines for Low Volume production. Hazardous or cytotoxic medications shall be prepared within the Class II, Type A externally exhausted hood using closed system transfer devices. RISK LEVELS AND BUD ASSIGNMENT Only low and medium risk CSPs are prepared at SMC. Risk levels are based on definitions found in USP Chapter 797. CSPs for immediate use may be prepared in patient care areas. Low risk CSPs may be prepared in either of the Class II Type A laminar flow biological safety cabinets (BSCs). CSPs prepared in either BSC shall be given a Beyond Use Date (BUD) of 12 hours (less if current literature states a shorter chemical stability). CSPs prepared within the Containment Aseptic Isolator (CAI) may be of either low or medium risk. Low risk CSPs compounded within the CAI shall be
given a BUD of no more than 48 hours at controlled room temperature, 14 days if refrigerated and not more than 45 days if frozen (or less if current literature states a shorter chemical stability). Medium risk CSPs prepared within the CAI shall be given a BUD of 30 hours at controlled room temperature, 9 days if stored under refrigeration, and 45 days if frozen (or less if current literature states a shorter chemical stability). General Operating Procedures Continuous Operation Biological safety cabinets and the containment aseptic isolator (Primary Engineering Controls, PECs) shall remain on at all times, Each unit shall be connected to a generator-supported emergency power outlet. In the case of a power interruption, each affected PEC must be decontaminated and allowed to run for 30 minutes prior to compounding. VectionIn order to minimize air currents that might introduce non-sterile air into PECs, personnel movement around PECs shall be minimized. Access to the compounding area is restricted to personnel actively involved in compounding tasks. CAI Pre-Filters Pre-filters atop the CAI shall be replaced every 3 months with high efficiency 20 x20 x4 HVAC filters. Receiving and Storage Upon receipt of items intended for use in the compounding area, check the container for damage. Packages shall be closely inspected for defects, damaged or broken seals, unusual odors, texture, or appearance. Damaged containers shall be reported to the Pharmacy Supervisor. Check the expiration date on the exterior of the container. Out of date items and those with near expiration dates should not be placed in stock. Place items with the nearest expiration date in front of others. Place case goods in designated storage areas on raised platforms or on shelves. Stocking the Compounding Area Prior to introduction into the compounding area, items should be removed from pasteboard/cardboard boxes. The expiration date should be checked. Items that are out of date or that have near expiration dates should not be stocked. Only clean, undamaged, unit of use or cellophane-wrapped containers should be placed in the compounding area. PEC Certification Newly installed primary engineering controls shall be certified operational prior to compounding by an independent certification service. Each PEC shall be re-certified every six months by an independent certification service. Records of certification shall be kept readily available for inspection. Should maintenance be required, it shall be scheduled as soon as possible. Restricted Items No food or drinks, candy, or chewing gum are allowed within the compounding area. Personal items such as outer clothing, purses, hats, cosmetics are not permitted in the compounding area. Cleaning and Disinfecting Products Products used in the cleaning and disinfection of the compounding are shall be approved by the infection control department and meet requirements set by USP Chapter 797. A list of these products shall be posted in the compounding area.
Personnel: Each employee engaged in compounding sterile products at SMC shall be currently licensed, registered and/or certified by The Alabama State Board of Pharmacy to perform assigned duties. Prior to compounding, and annually, each employee engaged in compounding CSP s shall receive didactic training and be successfully evaluated to perform the following Perform aseptic hand cleansing Perform disinfection of compounding surfaces Select and appropriately don protective garb Protect personnel and compounding environment from contamination by hazardous drugs Identify, weigh, and measure ingredients Manipulate sterile products aseptically Label and quality inspect CSP s Prior to compounding, and annually, each employee engaged in compounding CSP s shall Successfully complete medium risk media fill test Successfully complete a gloved fingertip sterility test Documentation shall be maintained for each person engaged in compounding CSP s that they are adequately skilled, educated, instructed, and trained to correctly perform and document compounding activities. Personnel failing any of the preceding requirements shall be immediately re-instructed and re-evaluated prior to resuming compounding. HAND HYGIENE AND GARBING PROCEDURE ALL PERSONNEL WHO COMPOUND STERILE PREPARATIONS SHALL SUCCESSFULLY COMPLETE EVALUATION PRIOR TO COMPOUNDING AND ANNUALLY THEREAFTER A QUALIFIED EVALUATOR SHALL ASSESS THESE COMPETENCIES ANY EMPLOYEE FAIILING TO MEET THESE COMPETENCIES SHALL BE IMMEDIATELY RETRAINED OR INSTRUCTED AND THEN RE- EVALUATED All persons engaged in compounding sterile preparations shall: 1. Present in appropriate manner and attire 2. Wear no cosmetics; remove all hand, wrist, and other visible jewelry orpiercings that can interfere with the effectiveness of PPE; fingernailsare neat, clean and of appropriate length (artificial nails or extendersare prohibited while working in the sterile compounding environment)
3. Bring no food, drink or chewing gum into compounding area 4. Don compounding garb in appropriate order: shoe covers, beard cover(if necessary), head cover (assuring all hair is contained), face mask (to cover bridge of nose to below chin) 5. Perform hand hygiene by wetting hands and forearms to elbows and washing using soap and warm water for at least 30 seconds, use pick to clean under fingernails with the first wash daily, rinse with warm water 6. Dry hands and forearms with nonshedding cloth or in warm air dryer 7. Don gown and ensure full closure, inspect for defects, replace if necessary 8. Disinfect hands using waterless alcohol-based surgical hand scrub, allow hands to dry 9. Don appropriate size sterile gloves, ensuring tight fit, examine gloves for defects, replace if necessary (See STERILE GLOVING PROCEDURE ) 10. Disinfect gloved hands by spraying with sterile 70% IPA prior to enteringhood, after touching contaminated surfaces, and frequently while compounding 11. Remove PPE on leaving the segregated compounding area: remove glovesperform hand hygiene, remove gown and hang up if to be re-used during that shift, remove and discardmask, head, beard and shoe covers STERILE GLOVING PROCEDURE This method uses a skin-to-skin glove-to-glove technique. The bare hand, although scrubbed, is not sterile and must not contact the exterior of the sterile gloves. The inverted cuff one the glove exposes the inner surface. The first glove is put on with skinto-skin technique, bare hand to inside cuff. The sterile fingers of that gloved hand then may touch the sterile exterior of the second glove, that is, glove-to-glove technique. With the left hand, grasp the cuff of the right glove on the fold Insert the right hand into the right glove and pull it on, leaving the cuff turned well down over the hand Slip the fingers of the gloved hand under the inverted cuff of the left glove Insert the left hand into the left glove and pull it on, leaving the cuff turned down over the hand With the fingers of the right hand, pull the cuff of the left glove up and over the cuff of the gown, without touching bare skin Repeat previous step for the right glove, using the left hand, thereby completely gloving the right hand COMPOUNDING AREA, CLEANING ANDDISINFECTION DAILY CLEANING Daily cleaning of the segregated compounding area shall be performed prior to compounding during a time that no sterile operations are in progress.
Personnel performing these operations shall be properly garbed with Personal Protective Equipment (PPE). See special PPE requirements for cleaning/decontamination of hazardous preparations BSC Cleaning shall be performed with approved disinfectants and cleansers. A list of approved agents shall be posted in the compounding area. Cleaning shall be performed in the following order 1. Clean floor 2. Clean sink 3. Clean work surfaces chairs and carts 4. Clean CAI 5. Clean Routine Procedures BSC 6. Clean Hazardous Preparations BSC FLOOR CLEANING PROCEDURE FLOORS ARE TO BE MOPPED DAILY AT THE BEGINNNING OF DAY SHIFT, PRIOR TO COMPOUNDING Cleaning shall take place while no aseptic operations are in progress Floors shall be cleaned with an approved disinfectant solution. A list of currently approved products shall be posted in the compounding area. Mops used to clean floors shall made of a low-shedding material Mop head is to be replaced daily Used mop heads are placed in a sealed container and sent to Environmental Services for cleaning, sanitizing and/or replacement. PROCEDURE: wet mop head with cleaner, begin mopping in area near CAI (Glove Box), then move to area around routine prep hood, then proceed toward the hazardous preparations BSC, ending at the exit door. Continue to spray mop/floor as needed to keep wet during mopping procedure. Allow area to dry Place used mop head in sealed container Record completion on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG DAILY SINK CLEANING PROCEDURE, COMPOUNDINGAREA SINK SHALL BE CLEANED DAILY PRIOR TO COMPOUNDING Cleaning shall take place when no aseptic operations are in progress Use approved disinfectant/cleanser. A list of approved cleaning agents shall be posted in the compounding area. PROCEDURE: Spray sink, faucet, and surrounding area with disinfectant/cleaning solution, wipe using non-sterile nonshedding cloth removing all visible spillage. On completion, discard cloths in standard waste container. Record completion on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG
DAILY WORK SURFACE AND CART AND CHAIR CLEANING WORK SURFACES AND CARTS AND CHAIRS SHALL BE CLEANED AND DISINFECTED DAILY PRIOR TO COMPOUNDING Cleaning shall take place when no aseptic operations are in progress Only approved disinfectants/cleansers should be used. A list of approved disinfectants and cleansers shall be posted in the compounding area. Use sterile water for irrigation and nonshedding cloths to remove heavy spillage or other water soluble residue Final cleaning and decontamination shall be performed using 70% isopropyl alcohol (IPA) and nonshedding cloths (sterile alcohol is not required.) Cleaning supplies are Pharmacy stock items Completion shall be recorded on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG DAILY CLEANING/DISINFECTING PROCEDURE: CONTAINMENT ASEPTIC ISOLATOR (CAI) When to Clean and Disinfect Cleaning and disinfecting is to be performed at the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface cleaning and disinfection when ongoing compounding activities are occurring, after spills, and when contamination is known or suspected Supplemental cleaning and disinfection shall be performed in the event of an accidental shutoff of the CAI and following a power failure Decontamination Procedure Supplies needed: 2 (two) spray bottles of sterile 70% IPA, extension wand with mop head and cover, nonshedding cloths, PVC gloves, and sterile water for irrigation or injection if needed* 1. Place supplies on clean cart in front of antechamber opening 2. Cover hands with PVC glove liner 3. Open access door to antechamber 4. Spray gloved hands with sterile 70% IPA in the draft from antechamber door 5. Use one spray bottle of alcohol to spray the second bottle, then place inside the antechamber for use during decontamination 6. Individually spray remaining supplies on all sides and place in antechamber 7. Once all supplies are in the antechamber, douse nonshedding cloth with sterile 70% IPA, spray door and surrounding area, wipe door and surrounding areas prone to turbulence 8. Close access door and wait at least 30 seconds 9. Place hands in barrier gloves 10. Open sliding door and move supplies into work area
11. Taking care not to wet the HEPA filter, spray all vertical surfaces with alcohol and wipe with nonshedding cloth, always clean top to bottom, back to front, use extension wand with mop head to clean remote areas* 12. Spray sleeves and gloves with alcohol and wipe with nonshedding cloth* 13. Spray on and under work tray with alcohol and wipe with nonshedding cloth* 14. Allow alcohol to dry 15. Remove cleaning supplies to antechamber, close door 16. Remove arms from barrier gloves 17. Open access door to antechamber 18. Spray gloved hands with alcohol in the draft from antechamber 19. Taking care not to wet the HEPA filter, spray all vertical surfaces of the antechamber and wipe with nonshedding cloth, always clean top to bottom, back to front* 20. Spray on and under work tray with alcohol and wipe with nonshedding cloth* 21. Remove supplies from antechamber, spray door and surrounding area with alcohol and wipe using nonshedding cloth 22. Repeat steps 17 through 21 for 2 nd antechamber 23. Allow alcohol to dry prior to compounding 24. Completion shall be recorded on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG *May use sterile water for irrigation or injection and nonshedding cloths to remove spillage, heavy contamination or water soluble residue prior to decontamination DAILY CLEANING AND DISINFECTION PROCEDURE, ROUTINE PROCEDURES BSC When to Clean and Disinfect Cleaning and disinfection is to be performed at the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface disinfection when ongoing compounding activities are occurring, after spills, and when contamination is known or suspected Supplemental cleaning/disinfection shall be performed in the event of an accidental shutoff of the BSC or CAI and following a power failure Decontamination Procedure Supplies needed: 2 (two) spray bottles of sterile 70% IPA, extension wand with mop head and cover, nonshedding cloths, sterile gloves, and sterile water for irrigation or injection if needed* 1. Ensure proper PPE in place including sterile gloves 2. Place supplies on clean cart 3. Spray gloved hands with sterile 70% IPA 4. Use one spray bottle of alcohol to spray 2 nd bottle prior to placing in BSC to be used for cleaning/disinfection 5. Spray remaining supplies on all sides and wipe with nonshedding cloth doused with alcohol prior to placing in BSC
6. Taking care not to wet the HEPA filter, spray all vertical surfaces with alcohol and wipe with nonshedding cloth, always clean top to bottom, back to front, use extension wand/mop to clean remote areas 7. Remove cleaning supplies from BSC, discard cloths in standard trash 8. Allow alcohol to dry prior to compounding 9. Completion shall be recorded on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG HAZARDOUS DRUGS BSC DAILY CLEANING ANDDISINFECTIONPROCEDURE When to Clean and Disinfect Cleaning and disinfection is to be performed at the beginning of each shift, before each batch, not longer than 30 minutes following the previous surface cleaning/disinfection when ongoing compounding activities are occurring, after spills, and when contamination is known or suspected Supplemental cleaning/disinfection shall be performed in the event of an accidental shutoff of the BSC, and following a power failure Prior to performing this procedure, personnel shall don shoe, head, beard and face covers, chemo gown and two pairs of chemo gloves Cleaning and Disinfection Procedure Supplies needed: 2 (two) spray bottles of sterile 70% IPA, nonshedding cloths, and sterile water for irrigation or injection if needed* 1. Ensure integrity of protective apparel 2. Spray gloved hands with sterile 70% IPA 3. Use one spray bottle of alcohol to spray 2 nd bottle prior to placing in BSC for use during cleaning/disinfection 4. Spray remaining supplies with sterile 70% IPA and wipe with nonshedding cloth prior to placing in BSC 5. Taking care not to wet the HEPA filter, spray all vertical surfaces with alcohol and wipe with nonshedding cloth, always clean top to bottom, back to front* 6. Spray work tray with alcohol and wipe with nonshedding cloth* 7. Remove cleaning supplies from BSC, place soiled nonshedding cloths in a chemo waste bin 8. Remove protective garb and seal in a chemo waste bin 9. Allow alcohol to dry prior to compounding 10. Completion shall be recorded on STERILE PREPARATIONS AREA, DAILY/MONTHLY ACTIVITY LOG *May use sterile water for irrigation or injection and nonshedding cloths to remove spillage, heavy contamination or water soluble residue prior to decontamination
MONTHLY CLEANING AND DISINFECTION During the first week of each month (or the first day thereafter that scheduling permits) the following areas within the Sterile Preparations Area shall be cleaned: ceiling, walls, shelving, storage bins, carts, waste bins, and horizontal dust-collecting surfaces. Cleaning shall take place when no sterile procedures are in progress. Use only hospital approved disinfectants and cleaners. A list of approved products shall be posted in the compounding area. Begin process by donning personal protective equipment, including face mask. Clean ceiling with mop wetted with a hospital approved disinfectant/cleaner, begin with clean mop head, use only enough liquid to wet surface, avoid dripping onto personnel and surfaces Using same mop, repeat above procedure for walls Remove all bins and stock items from shelving, clean shelves with hospital approved disinfectant, then wipe with 70% IPA and nonshedding cloths Remove stock from bins, clean bins inside and out with hospital approved disinfectant, then wipe with 70% IPA and nonshedding cloths, replace stock and bins Thoroughly clean carts, first with hospital approved disinfectant, then wipe with 70% IPA. Clean top, bottom, undersides of shelves and wheels Thoroughly clean chairs, top to bottom, including wheels with hospital approved disinfectant, then wipe with 70% IPA Wipe all horizontal surfaces with nonshedding clothssaturated with hospital approved disinfectant, then wipe with 70% IPA, use care to avoid creating air born dust Clean waste bins inside and out, first with hospital approved disinfectant, then 70% IPA Place mop head in designated receptacle, discard soiled cloths in standard waste bin Discard personal protective in appropriate waste container Allow cleaning fluids to dry prior to compounding ACTION LEVELS Hand Hygiene In the event that an employee s annual gloved fingertip test returns positive for 4 or more colony forming units (CFUs), the employee shall be re-trained in proper garbing and gowning procedures. The employee must then perform the gloved fingertip test 3 successive times with zero growth before resuming compounding activities. In the event that an initial (new employee, trainee) gloved fingertip test is positive for 1 or more CFUs, the employee must be re-trained and complete 3 successive tests with zero CFUs before being allowed to continue training. PEC Viable & Non-Viable Particle Testing
In the event that particle testing within either Class II Type A cabinetresults in the growth of 2or more viable colonies, or greater than 3,250 non-viable particles (0.5 micron or >) per cubic meter, the following procedures shall be performed. 1. The BSC shall be thoroughly decontaminated using approved disinfectant and cleaning solutions. Particular care shall be taken to ensure that the disinfectants used are effective against the organisms cultured. 2. The BSC shall be inspected for any malfunctioning parts. 3. The HEPA filter shall be inspected for damage. 4. Any necessary repairs shall be performed as soon as possible. 5. Repeat testing shall be performed with the next scheduled certification. In the event that particle testing within the Containment Aseptic Isolator (CAI) results in the growth of 2 or more viable colonies, or greater than 3,250 nonviable particles (0.5 micron or >) per cubic meter, the following procedures shall be performed. 1. The CAI shall be thoroughly decontaminated using approved disinfectants and cleaning solutions. Particular care shall be taken to ensure that the disinfectants are effective against the organisms cultured. 2. The CAI shall be inspected for malfunctioning parts. 3. The HEPA filter shall be inspected for damage. 4. Any necessary repairs shall be performed as soon as possible 5. The pre-filters shall be replaced. 6. The sleeves and gloves shall be replaced. 7. Repeat testing shall be performed with the next scheduled certification. Scheduling of CSPs 1. STAT Orders All STAT orders are prepared immediately and the nursingunit is notified when the preparation is ready. 2. Routine Orders All new routine orders are prepared on a first-come, first-servebasis.these orders have priority over batch refilling. The I.V. Therapy Department prepares a twenty-four hoursupply ofadmixtures except for those that are not stablefor the 24-hour period. The routine orders needed for administrationfrom 12:00noon until 12:00midnight are prepared during mid-morning. Orders needed foradministration from 12:00 midnightuntil 12:00noon the following day are prepared during mid-afternoon. 3. I.V. Patient List The I.V. patient list is generated each morning for each nursing unit.this allows the pharmacists to keep the I.V. Admixture properlyscheduled. The I.V. technician rounds to each nursing unit daily to obtain accuratecount as per each patient.
If an admixture during the day is running ahead or behind schedule, thenurse contacts the I.V. Therapy Department (Ext. 1667) by telephoneand indicates the appropriate time the next admixture is needed. Theadmixture schedule is then adjusted accordingly. Computer Order Entry/verification Label The admixture procedure shall begin only after the physician s order has beenverified by a pharmacistthe following shall be reviewed by the pharmacist prior to preparingthe admixture. 1. Base solution and final volume 2. Medication and dosage 3. Concentration of medication 4. Compatibility and Stability of Fluid and Medication 5. Confirmation of correct infusion rate (rates of infusion shall be expressed in ml/hr (milliliters per hour). 6. Review of patient allergies. 7. Confirmation that the medication is appropriate for patient s diagnosis 8. Pharmacist-Physician Consultation If any of the above factors are out of normal range, the pharmacist shall consult the physician for future orders. 9. In the event there is an order change, the pharmacist shall record same on the patient s chart as stated in the Policy and Procedure Manual for the Department of Pharmacy. When the above information is put into the computer, the followinglabel is printed via the computer printer with the followinginformation. a) Patient s name and room number b) hospital number c) Date and time of preparation d) of administration e) Basic solution f) Volume of basic solution g) Name and amount/dose of medication added h) Necessary supplemental instructions Prior to dispensing, the following information shall be added to the label a) If prepared by a technician, his/her initials AND the initials of the pharmacist checking the final product b) If prepared by a pharmacist, his/her initials Preparation of the Admixture
1. The label is placed on the work counter. Using the informationon the label as the guide, select medications, diluents, and suppliesnecessary to admit the preparation. Visually inspect all supplies anddiscard/replace any found defective. 2. Syringes and other products cased within sterile packaging are opened atthe interface of the PEC. All products not in sterile containers are sprayed with sterile 70% isopropyl alcohol or wipedwith lint-free wipes soaked with sterile 70% isopropyl alcohol prior to placing them into the work area. 3. All work in the BSCshall be performed (6) inches orgreater back from the front edge of the hood counter. Thefirst six (6) inches of the hood counter is the most easilycontaminated due to convection currents from non-sterile room air. 4. Critical sites shall be wiped with sterile pads saturated with 70%isopropyl alcohol. 5. Withdrawing and Addition of Medication The contents ampules and vials are always withdrawn by using a syringe. Only one needle and syringe is used for eachoperation and then discarded. No needle and syringe arere-used for more than one additive. a) Ampule When the additive container is glass ampule,the neck of the ampule is first swabbed with 70% alcohol.the ampule is then broken open by placing a sterilepad over the stem of the ampule and snappingit sharply away from the body of the ampule. The ampuletop and pad are immediately discarded. Themeniscus of the medication in the ampule is checked forlint particles from the gauze and also glass particles.when the medication is withdrawn, the needle is turnedopen and slightly downward. The downward angle of theampule is increased as the medication is withdrawn untilthe desired quantity is withdrawn. The ampule is then setaside to be placed with the final product for checking andthe medication is injected into the primary basic solution.after withdrawal from ampule, the needle is replaced with a filter needle prior to injecting the medication into the final container. b) Vial When the additive container is a vial, the rubberstopper is patted with 70% alcohol swab prior to theinitial puncture of the rubber stopper with the needle forreconstitution of the additive. The powdered medicationis then reconstituted with the proper fluid. When enteringthe rubber stopper with the needle, entry is made with thebeveled side of the needle up and with slight downwardpressure. The reconstituted fluid is forced into the vialand the pressure isreleased by withdrawing an equalvolume of air. The vial is shaken vigorously until the drugis in solution. After insuring there are no floaters in the vial,the quantity required is withdrawn and injected into the primary basic fluid. 6. Disposition of Needle and Syringe After injection of themedication into the basic primary fluid, the needle and syringe are disposed of in a puncture-proof
needle container. Containersshall be replaced when they are no more than 2/3 full. Prior to dispensing, a product-specific BUD label is placed on the container. 7. Label Location The label is affixed to the inverted bottle or bag in a location whereby the name of the primary basic fluid,manufacturer s lot number andexpiration date are visible. 8. The admixture is inspected for defects and particulate matter, also labelinformation is verified. 9. Final Check Only a pharmacist may perform the final check and approval of an admixed product. He/she shall indicate approval by placing his/her initials on the label. No admixture may leave the Pharmacy prior to final approval. 10. Refrigeration The checked admixture is placed in the refrigerator, when appropriate in the I.V. Admixture Room ready for delivery. The temperature in the refrigerator is maintained at 36 to 40 degreesfahrenheit. This is checked and documented daily a daily log. 11. Delivery Routine I.V. admixtures are picked up by the nursing personnel and delivered to the respective nursing unit where theadmixture is refrigerated until ready for use. STAT I.V. admixtures will be prepared immediately and the nursingunit will be notified when the preparation is ready. Personnel Training and Orientation: Before a pharmacist or technician may prepare an I.V. admixture, thefollowing training/orientation schedule and checklist must be satisfactorily completed. 1. The training manual for central intravenous admixturepersonnel and the policy and procedure manual for the Sterile Preparations Area shall be thoroughly reviewed by the trainee. 2. The trainee will observe the I.V. pharmacist in the completion of all duties associated with the program. Working outside the PEC s, using practice supplies & materials, the trainee will demonstrate techniques necessary for I.V. preparation. 3. The trainee shall successfully complete a gloved fingertip sterility test. The test is repeated until the trainee completes 3 successive tests with zero growth. After successful completion of the fingertip test, the trainee must successfully complete a medium risk media fill test. 4. The trainee shall successfully complete written and audiovisual training.
5. Completion: Only when the trainee, through testing andobservation, demonstrates competency in all aspects of I.V. preparation, is that individual allowed to independently prepare sterile solution for patients. I.V. Admixture Orientation and Training Checklist 1) Initial Study: a) Self-study of training materials b) Self-study of Policy and Procedure manual 2) General Procedure Competency Review/Demonstration: a) Gowning and garbing procedures i) Selecting and doning of garments ii) Hand washingtechnique iii) Personal cleanliness/dress code b) Laminar Flow Hoods (BSC s and CAI) i) Decontamination ii) Hood certification iii) Power and power interruptions iv) Work surfaces and placement of supplies v) Air flow in and around PEC c) I.V. Room Cleanliness & Recordkeeping i) Daily cleaning procedures ii) Monthly cleaning procedures iii) Daily temperature and airflow logs iv) Personal items and food/drink v) General housekeeping responsibilities d) Multi-dose and single use containers i) Proper entry techniques ii) Expiration times & dates e) Beyond Use Dating and Expiration Dating i) Biological safety cabinets ii) Containment Isolator f) Access and review of computerized patient information i) Name of patient ii) Age of patient iii) Bed and room number of patient iv) Patient s physician v) Patient s hospital number vi) Drug allergies vii) Disease state information viii) Weight
g) Computer Order Entry i) Basic fluid and volume ii) Medication to be added iii) Compatibility of fluid and medication to be added, information resources iv) Infusion rate calculation h) Preparation of Label i) Label generation at time of order entry ii) Supplementary label generation iii) Ancillary labels 3) Compounding Competency Review/Demonstration a) Basic Admixture Technique i) Choosing correct medications and diluents ii) Dose calculations iii) Admixture technique iv) Re-confirm correct medication/diluent/volumes v) Proper handling of waste b) Labeling Final Product i) Correct placement of label ii) Confirming correct information iii) Addition of ancillary labels and seals iv) Risk level determination v) BUD determination c) Final verification i.) Confirm process completed correctly ii.) Visually inspect final product 4) Storage prior to delivery i) Refrigeration ii) Room temp a) Delivery options b) Order Changes and Revisions c) Handling of discontinued I.V. medications d) Charge and Credit Procedures